Quality Engineer- Medical Devices

General Information
Location  377 Simarano Drive
Suite 302
Marlborough, MA 01752
United States
Employee Type  Exempt FT (D)
Job Category  Engineering

Contribute to the development of new products and sustaining of legacy products with a focus on Manufacturing Quality and Compliance activities. 


  • Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues
  • Assist with maintenance of calibration system
  • Support Manufacturing Engineering in the creation, release and maintenance of DHR, routers, bills of material, and specifications for manufacturing
  • Perform incoming inspection review and disposition of product components and subsystems.
  • Develop and/or revise routine procedures, work instructions, and test methods.
    • Document all activities in compliance with applicable medical standards, regulations, and guidelines.
    • Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
    • Support  management of new and approved suppliers; participate in internal and supplier audits.
    • Utilize problem solving tools to analyze and identify root causes and implementing corrective actions.
    • Make decisions and propose solutions based on calculated risks identified through data analysis.

Experience Desired:

  • 3-5 years of manufacturing experience with Class II/III electro-mechanical medical device field
  • Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred
  • Extensive working knowledge of 21 CFR 820 and ISO 13485
  • Strong working knowledge of Microsoft Word and Excel
  • Hands-on experience with the following manufacturing processes: Plastic Injection Molding, Metal Fabrication, PC Boards, ESD controls, Cabling, Clean room
  • Experience with lasers and optical technologies desired, but not necessary
  • Prior start-up experience is a plus


Education Required:

  • Bachelor's Degree in electrical engineering or similar engineering field


Personal Requirements:

  • Self-starter, with demonstrated ability to follow-through and strong attention to detail
  • Excellent oral and written communication, and interpersonal skills
  • Must be able to interact with customers, consultants, and suppliers
  • Ability to work in an environment with competing priorities is necessary
  • Must be able to work in a cross-functional team environment
  • Physical ability to lift and carry objects up to 25 lbs.



This position must meet Export Control compliance requirements, therefore a “US Person” as defined by 22C.F.R. §120.15 are required. “US Person” includes US Citizen, lawful permanent resident, refugee, asylee.   License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.


The following link will take you to the government site with the list of Country Group B: https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file